Bivona

GUDID 15019517218916

Smiths Medical ASD, Inc.

Basic tracheostomy tube, reusable
Primary Device ID15019517218916
NIH Device Record Key20194c9c-7772-4f38-a5cd-2651ef63749f
Commercial Distribution StatusIn Commercial Distribution
Brand NameBivona
Version Model NumberFU20AN35NGE824N
Company DUNS082005361
Company NameSmiths Medical ASD, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS115019517218916 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JOHTube tracheostomy and tube cuff

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[15019517218916]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-11
Device Publish Date2020-02-03

On-Brand Devices [Bivona]

0502131201378167FHXL90
0502131201377467FHXL80
0502131201376767FHXL70
0502131201375067FHXL60
15019517185577FU19CN45NGF924N
15019517185560HU19CS70NSC925N
15019517185553FU19CN30NGE926N
15019517185539FU19CN45NSC927N
15019517185522ST19CN55NGF928N
15019517185508FT19CN40NGE929N
15019517185492FT19CN35NGE930N
15019517185485SP19CN40NSC931N
15019517185461HU19CS70NSC932N
15019517185430FP19CN40NGE100N
15019517185423FT16CN45NSA015N
15019517185416FT19CN40NGA085N
15019517185409SU18AN45NGG018N
15019517185393FT19CN40NSA099N
15019517185386FT19CN50NSF098N
15019517185379FP19CN50NGA101N
15019517185362FT19CN40NGE097N
15019517185331FT19CN80NSC096N
15019517185294FT19CN40NSG095N
15019517185270SU19CN40NGF094N
15019517185751FT19CN30NGE917N
15019517185744FT19CN35NGE918N
15019517185720FT19CN35NGE919N
15019517185713FT19CN35NGE920N
15019517185706FA19CN85NSC921N
15019517185669SU14FN60NSC093N
15019517185652HA19CS80ZSC112N
15019517185638FU19CN35NSA109N
15019517185621FT19CN30NGC111N
15019517185614FT19CN35NGC110N
15019517185607FT19CN40NSA108N
15019517185591FT19CN40NGA103N
15019517185584FT19CN40NGA102N
15019517185546FT19CN40NGE104N
15019517185515FT19CN40NGE107N
15019517185478FT19CN40NGF106N
15019517185454XT19CS45NSF105N
15019517185447FU19CN35NGE093N
15019517185935XT19CS80NSC905N
15019517185928SU19CN45NSC906N
15019517185911FT19CN70NSC908N
15019517185904ST19CN55NSB909N
15019517185898FT19CN30NGC910N
15019517185881FT19CN35NGC911N
15019517185874FT19CN50NSC912N
15019517185867FU19CN55NSC913N

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.